Modlity and system for casting diabetic and neuropathic plantar foot ulcerations and treating defects that limit range of motion.

ABSTRACT

A system that is clinically and effically sound, consisting of proprietary components that not only address the needs of the clinician but are universally utilized in a concise protocol covering a wide range of indications and conditions.

RELATED APPLICATIONS

The present application is related to U.S. Pat. No. 6,974,431, issuedDec. 12, 2005, included by reference herein.

The present application is related to U.S. Pat. No. 4,817,590, issuedApr. 4, 1989, included by reference herein.

The present application is related to U.S. Pat. No. 4,235,228, issuedNov. 25, 1980, included by reference herein.

The present application is related to U.S. Pat. No. 3,900,024, issuedAug. 19, 1975, included by reference herein.

The present application is related to U.S. Pat. No. 3,415,243, issuedDec. 10, 1968, included by reference herein.

The present application is related to U.S. Pat. No. 3,307,537, issuedMar. 7, 1967, included by reference herein.

No known patents for serial casting

FIELD OF THE INVENTION

The present invention relates to total contact casting and, moreparticularly, to a unique turn key, user friendly modality that providesintimate contact, and promotes better body mechanics, which have provento be the key components in healing diabetic and neuropathic footulceration. The system accomodates a variety of conditions that lead torange of motion disorders and allows the condition to be treated whilemaintaing quality of life.

BACKGROUND OF THE INVENTION

Diabetic and neuropathic foot ulcerations can be challenging wounds toheal. The etiology of these ulcerations can vary from compromised bloodflow to arthritis, and other conditions and co-morbidities. Totalcontact casts have been utilized for decades for the treatment ofdiabetic, neuropathic foot ulcerations, as well as charcot footdeformities.

Total Contact Casting was introduced to the United States nearly 70years ago from the leper colonies of India and was adopted by ourclinicians for the treatment of neuropathic and diabetic footulcerations. The total contact cast configuration and applicationprotocol has remained almost exactly the same since the introductionwith the exception of new lighter weight materials. This approach tototal contact casting is the first new cast configuration that is trulyunique from all other systems and has proven to be clinically effective.

Total Contact Casting as described in the name is meant to have as closeto intimate contact with the patients leg as possible. This intimatecontact is designed to secure the foot and leg in a position that allowsfor the patient to ambulate while removing the pressure and propulsiveforces from the wound and not allowing the foot to move in the cast. Thetotal contact cast should be applied weekly with the exception of thefirst week at which the cast should be re-applied during the first 48 to72 hours to accommodate the reduction of swelling and edema in the leg.

A typical total contact cast is applied in several layers. These layersare comprised of a stockinette, a felt pad covering the length of thetibia, a pad covering the lateral and medial maleolous, a layer of rigidplaster, one to two layers of cast padding, a layer of fiberglass, aposterior splint that is fabricated out of a roll of fiberglass tape,unfurled and folded to be three to four layers thick when applied, arigid walker plate, a rubber walker heel, and a final roll of fiberglassthat the clinician will continue rubbing until the cast sets up,approximately ten to twelve minutes post application.

Even the casting system identified in U.S. Pat. No. 6,974,431 is thesame as the original total contact cast configuration except in a kitform. There are inherent flaws that all of these accepted existing totalcontact casting systems have in common that have not been addressed.

Currently less than 2% of clinicians utilize total contact casting totreat their diabetic and neuropathic foot ulcer patients. Pastobjections to total contact casting were the time it takes to apply, thecost of materials, consistency of application, weight of a cast, andpatients developing back and hip pains due to the change in the lengthof the leg which greatly effects the body mechanics of these alreadycompromised patients.

In addition to the diabetic and neuropathic ulceration application, thisversatile system can be utilized as a serial casting system forimproving the range of motion for burn, cerebral pulsy, spinal bifida,spinal cord injury, muscular dystrophy, idiopathic toe walking, andperipheral neuropathy patients. Applied weekly, gradually increasing therange of motion to a specific limb. This is a non-surgical approachaimed at reducing muscle tightness around the joint that is limiting therange of motion and functional mobility.

Other solutions in existence have merely tried to address the time ofapplication and consistency issues without getting to the core of theproblem. Jensen and Gillin developed a cast kit that incorporated all ofthe components that the clinician would typically assemble separatelyinto one box. The components in the Jensen and Gillin system areessentially the same as any clinician would pull from their inventorywith the exception of a unique felt pad that takes what would be twoindividual pads, the tibial crest and the maleoli pad and connected themas a one piece system. (U.S. Pat. No. 6,974,431)

There is an existing system that resembles a fiberglass sock. Thissystem is not rigid, does not provide intimate contact to the leg, andhas to be placed in a removable walker boot to support the system.

Other casting systems discovered during the patent search were designedfor stabilizing fractured bones and not for the treatment of a specificcondition such as diabetic and neuropathic foot ulcerations.

Currently serial casting consists of specific products that areassembled by a technician to accommodate the defect. This system isgeared towards providing all of the components to accommodate a widerange of indications. Additionally this system is universal and willaccommodate children to adults.

Conventional total contact casting systems tend to be time consuming,extend the length of limb, can create additional ulcerations, and aredifficult to remove.

The Jensen and Gillin system follows the traditional total contact castconfiguration with exception to the felt pad that they utilize over thetibia of the leg. Historically there was a separate pad that runsdistally from just under the fibular head down to the dorsal aspect ofthe foot. Additionally there were two felt pads that covered themaleolous to protect them during removal. The pads are taped onto thestockinette while preparing for the cast. Jensen and Gillin connectedthe maleoli pads creating a one piece system. The Jensen/Gillin systemis very time consuming and in most cases requires two clinicians toapply. Once the final roll of cast tape is utilized a clinician has tocontinue rubbing the fiberglass so that it doesn't un-roll while settingup. This requires approximately 20 minutes to apply and cure.

Another key factor that has effected the popularity of casting arecomplaints by the patients of hip and back pain. These systems are beingutilized for five to eight weeks so the patient is in the cast for quitesome time. Existing total contact casting systems utilize several rollsof padding, plaster, and fiberglass to build up the body of the cast.Prior to the application of the rubber walker heel and the last roll offiberglass a thick rigid plate is placed on the plantar surface of thefoot extending from the heel to just under the toes. This plate adds asignificant amount of length to the cast as it is not just the thicknessof he plate but the fact that it is being balanced at the heel andsolace of the foot which are the high points of the plantar footsurface. The plate is utilized to help re-distribute the weight of thepatient evenly over the entire foot. Subsequently the plate increasesthe length of the leg making it disproportionately longer than the otherleg thus throwing off the natural body mechanics and causing hip andback pain. Prior systems tend to use traditional components that arevery heavy which just exacerbate these conditions for the patient. TheJensen/Gillin system incorporates the heavy materials and a very thickwalker plate which doesn't address the issues that have been associatedwith total contact casting for decades.

Total Contact Casting is meant to have very close contact with thepatients limb. This is important in order to assure maximum pressureoffloading to the ulcer and minimize movement in the cast. Prior systemsutilize cast padding as the first layer covering the stockinette andfelt tibial crest pad. This padding breaks down and compresses creatingspace within the cast. Subsequently, the foot pistons forward andbackwards in the cast creating additional ulcerations and pressurepoints.

Contact Cast removal has been a long standing issue and in several caseswhere patients have ended up with serious injuries as a result. Priortotal contact casting systems are cut down the center of the tibia, overthe tibial crest pad, along the dorsum of the foot, over the toes, andthen wedges are cut over the maleoli pads. The cast has to spread at thecenter while supporting the leg with opposing pressure until the castbreaks. This requires a lot of strength and can be very time consuming.Occasionally patients have excessive swelling and end up at theemergency room for removal. A traditional below the knee cast cuts onthe lateral and medial sides of the leg with the center removing so thecast literally falls off of the leg. There have been numerous situationswhere patients have gone to emergency and since the typical doctor isnot familiar with the total contact cast removal have cut into andburned the patients legs. None of the prior systems have addressed thischronic struggle up to this time.

There are no known existing serial casting systems commerciallyavailable for clinicians to utilize.

It is therefore an object of the invention to provide a turn key, userfriendly casting system.

It is another object of the invention to provide a versatile castingsystem that promotes consistency of application.

It is another object of the invention to provide a casting system thatcan be utilized for a variety of defects and conditions.

It is another object of the invention to provide a casting system thatproduces re-producible clinical outcomes.

SUMMARY OF THE INVENTION

In accordance with the present invention, there is provided a systemthat is clinically and effically sound, consisting of proprietarycomponents that not only address the needs of the clinician but areuniversally utilized in a concise protocol covering a wide range ofindications and conditions.

BRIEF DESCRIPTION OF THE DRAWINGS

A complete understanding of the present invention may be obtained byreference to the accompanying drawings, when considered in conjunctionwith the subsequent, detailed description, in which:

FIG. 1 is a front view of a patient's leg and foot with a wound dressingcovering the defect;

FIG. 2 is a front view of a patient's leg and foot with first layerwhich is a protective stocking;

FIG. 3 is a front view of a patient's leg covered with a stocking andthe self adhesive protective toe cover applied and trimmed to thecontour of foot;

FIG. 4 is a front detail view of a patients leg and foot ready to cast,prepared with the stocking, toe protector, lateral and medial offloadingstrips, maleoli strips, tibial bridge, and mid-tibial pad;

FIG. 5 is a right detail view of a patient's leg and foot in the proneposition, prepared for casting;

FIG. 6 is a right detail view of a patients leg and foot with the firstroll of elastic plaster applied over the stocking, foam toe protector,and proprietary felt offloading and maleoli strips, providing intimatecontact with the leg;

FIG. 7 is a right detail view of a patient's leg and foot with firstroll of fiberglass tape covering the elastic plaster, essential for thecorrect positioning of the foot providing a rigid shell adding strengthto the cast;

FIG. 8 is a right detail view of a patient's leg and foot with the extrastrength pre-fabricated posterior splint covering the planter surfacehanging over the posterior aspect of the leg and secured at the proximalend with the excess stocking;

FIG. 9 is a right detail view of a patients leg and foot with the finalroll of fiberglass tape applied, securing the proprietary rocker walker,aligned with the anterior tibia, while forming the pre-fabricatedposterior splint to the patients limb providing maximum support to thefoot and ankle; and

FIG. 10 is a right detail view of a patient's leg and foot with acompleted cast application, and the self adhering dressing securing theloose end of the fiberglass tape.

For purposes of clarity and brevity, like elements and components willbear the same designations and numbering throughout the Figures.

DESCRIPTION OF THE PREFERRED EMBODIMENT

FIG. 1 is a front view of a patient's leg dressed and ready for castpreparation.

FIG. 2 is a front view of a patient's leg with the first protectiveinitial leg cover.

FIG. 3 is a front view of a patient's foot with proprietary toeprotector, trimmed to fit contour of the foot.

FIG. 4 is a front detail view of a patient's leg prepared withproprietary felt lateral and medial offloading and maleoli strips.

FIG. 5 is a right detail view of a patient's leg in prone position,prepared for casting.

FIG. 6 is a right detail view of a patient's leg with initial roll ofelastic plaster casting material.

FIG. 7 is a right detail view of a patient's leg with first roll offiberglass that is wet and rolled to cover to just below fibular head.

FIG. 8 is a right detail view of a patient's leg with the proprietaryextra strength pre-fabricated splint.

FIG. 9 is a right detail view of a patient's leg and foot with finalroll of fiberglass securing proprietary rubber rocker walker.

FIG. 10 is a right detail view of a patient's leg with finished cast.

Since other modifications and changes varied to fit particular operatingrequirements and environments will be apparent to those skilled in theart, the invention is not considered limited to the example chosen forpurposes of disclosure, and covers all changes and modifications whichdo not constitute departures from the true spirit and scope of thisinvention.

Having thus described the invention, what is desired to be protected byLetters Patent is presented in the subsequently appended claims.

1. A new modlity and system for casting diabetic and neuropathic plantarfoot ulcerations and treating defects that limit range of motion. forremoving the propulsive forces from the ulceration to expedite healingwhile promoting consitancy of application for the clinician, as well asreducing muscle tightness that occur for a variety of reasons andconditions, comprising: means for is to address the need of the specificwound; means for an initial covering, protecting the leg and providing asurface for the attachment of proprietary felt medial and lateraloffloading and maleoli strips; means for the protection of the toesduring casting and removal of the cast, rigidly connected to said meansfor an initial covering, protecting the leg and providing a surface forthe attachment of proprietary felt medial and lateral offloading andmaleoli strips; means for adding specific pressure to the leg whichassists in proper distribution of weight and ensures easy removal,rigidly connected to said means for an initial covering, protecting theleg and providing a surface for the attachment of proprietary feltmedial and lateral offloading and maleoli strips; means for assisting inproper distribution of weight and allows for easy removal, rigidlyconnected to said means for an initial covering, protecting the leg andproviding a surface for the attachment of proprietary felt medial andlateral offloading and maleoli strips; means for protection of theproximal tibial crest, rigidly connected to said means for an initialcovering, protecting the leg and providing a surface for the attachmentof proprietary felt medial and lateral offloading and maleoli strips;means for additional protection against rubbing of the prominent sectionof the tibial crest, rigidly connected to said means for an initialcovering, protecting the leg and providing a surface for the attachmentof proprietary felt medial and lateral offloading and maleoli strips;means for first layer of rigid materal in an elastic composit providingthe intimate contact required to eleminate the risk of friction to thelimb; means for providing a hard rigid shell over the elastic plaster tosecure the position of the limb to ensure proper body mechanics, rigidlyconnected to said means for first layer of rigid materal in an elasticcomposit providing the intimate contact required to eleminate the riskof friction to the limb; means for purpose of supporting the limb whilere-distributing the patient's weight over the surface of the foot,removing the direct pressure from the wound, rigidly connected to saidmeans for providing a hard rigid shell over the elastic plaster tosecure the position of the limb to ensure proper body mechanics; meansfor securing the extra strength posterior splint as well as anchoringthe proprietary rocker walker in position; means for allowing thepatient to ambulate normally while promoting a natural gate due to thearch of the walker pads, rigidly connected to said means for securingthe extra strength posterior splint as well as anchoring the proprietaryrocker walker in position; and means for securing the loose end of thefinal roll of fiberglass so that the fiberglass doesn't unravel, rigidlyconnected to said means for securing the extra strength posterior splintas well as anchoring the proprietary rocker walker in position.
 2. Thenew modlity and system for casting diabetic and neuropathic plantar footulcerations and treating defects that limit range of motion. inaccordance with claim 1, wherein said means for is to address the needof the specific wound comprises a 101 preferred wound dressing.
 3. Thenew modlity and system for casting diabetic and neuropathic plantar footulcerations and treating defects that limit range of motion. inaccordance with claim 1, wherein said means for an initial covering,protecting the leg and providing a surface for the attachment ofproprietary felt medial and lateral offloading and maleoli stripscomprises a new attribute 1 102 stockinette.
 4. The new modlity andsystem for casting diabetic and neuropathic plantar foot ulcerations andtreating defects that limit range of motion. in accordance with claim 1,wherein said means for the protection of the toes during casting andremoval of the cast comprises a 103 self adhesive foam toe protector. 5.The new modlity and system for casting diabetic and neuropathic plantarfoot ulcerations and treating defects that limit range of motion. inaccordance with claim 1, wherein said means for adding specific pressureto the leg which assists in proper distribution of weight and ensureseasy removal comprises a 104 felt self adhesive lateral/medialoffloading strips.
 6. The new modlity and system for casting diabeticand neuropathic plantar foot ulcerations and treating defects that limitrange of motion. in accordance with claim 1, wherein said means forassisting in proper distribution of weight and allows for easy removalcomprises a 105 felt self adhesive lateral/medial maleoli strips.
 7. Thenew modlity and system for casting diabetic and neuropathic plantar footulcerations and treating defects that limit range of motion. inaccordance with claim 1, wherein said means for protection of theproximal tibial crest comprises a 106 felt self adhesive tibial bridge.8. The new modlity and system for casting diabetic and neuropathicplantar foot ulcerations and treating defects that limit range ofmotion. in accordance with claim 1, wherein said means for additionalprotection against rubbing of the prominent section of the tibial crestcomprises a 107 felt self adhesive mid-tibial protector.
 9. The newmodlity and system for casting diabetic and neuropathic plantar footulcerations and treating defects that limit range of motion. inaccordance with claim 1, wherein said means for first layer of rigidmateral in an elastic composit providing the intimate contact requiredto eleminate the risk of friction to the limb comprises a 108 elasticplaster roll.
 10. The new modlity and system for casting diabetic andneuropathic plantar foot ulcerations and treating defects that limitrange of motion. in accordance with claim 1, wherein said means forproviding a hard rigid shell over the elastic plaster to secure theposition of the limb to ensure proper body mechanics comprises a 109first roll of fiberglass tape.
 11. The new modlity and system forcasting diabetic and neuropathic plantar foot ulcerations and treatingdefects that limit range of motion. in accordance with claim 1, whereinsaid means for purpose of supporting the limb while re-distributing thepatient's weight over the surface of the foot, removing the directpressure from the wound comprises a 110 extra strength pre-fabricatedposterior splint.
 12. The new modlity and system for casting diabeticand neuropathic plantar foot ulcerations and treating defects that limitrange of motion. in accordance with claim 1, wherein said means forsecuring the extra strength posterior splint as well as anchoring theproprietary rocker walker in position comprises a 112 final fiberglassroll.
 13. The new modlity and system for casting diabetic andneuropathic plantar foot ulcerations and treating defects that limitrange of motion. in accordance with claim 1, wherein said means forallowing the patient to ambulate normally while promoting a natural gatedue to the arch of the walker pads comprises a 111 proprietary rubberrocker walker heel.
 14. The new modlity and system for casting diabeticand neuropathic plantar foot ulcerations and treating defects that limitrange of motion. in accordance with claim 1, wherein said means forsecuring the loose end of the final roll of fiberglass so that thefiberglass doesn't unravel comprises a 113 self adhering dressing.
 15. Anew modlity and system for casting diabetic and neuropathic plantar footulcerations and treating defects that limit range of motion. forremoving the propulsive forces from the ulceration to expedite healingwhile promoting consitancy of application for the clinician, as well asreducing muscle tightness that occur for a variety of reasons andconditions, comprising: a 101 preferred wound dressing, for is toaddress the need of the specific wound; a new attribute 1 102stockinette, for an initial covering, protecting the leg and providing asurface for the attachment of proprietary felt medial and lateraloffloading and maleoli strips; a 103 self adhesive foam toe protector,for the protection of the toes during casting and removal of the cast,rigidly connected to said 102 stockinette; a 104 felt self adhesivelateral/medial offloading strips, for adding specific pressure to theleg which assists in proper distribution of weight and ensures easyremoval, rigidly connected to said 102 stockinette; a 105 felt selfadhesive lateral/medial maleoli strips, for assisting in properdistribution of weight and allows for easy removal, rigidly connected tosaid 102 stockinette; a 106 felt self adhesive tibial bridge, forprotection of the proximal tibial crest, rigidly connected to said 102stockinette; a 107 felt self adhesive mid-tibial protector, foradditional protection against rubbing of the prominent section of thetibial crest, rigidly connected to said 102 stockinette; a 108 elasticplaster roll, for first layer of rigid materal in an elastic compositproviding the intimate contact required to eleminate the risk offriction to the limb; a 109 first roll of fiberglass tape, for providinga hard rigid shell over the elastic plaster to secure the position ofthe limb to ensure proper body mechanics, rigidly connected to said 108elastic plaster roll; a 110 extra strength pre-fabricated posteriorsplint, for purpose of supporting the limb while re-distributing thepatient's weight over the surface of the foot, removing the directpressure from the wound, rigidly connected to said 109 first roll offiberglass tape; a 112 final fiberglass roll, for securing the extrastrength posterior splint as well as anchoring the proprietary rockerwalker in position; a 111 proprietary rubber rocker walker heel, forallowing the patient to ambulate normally while promoting a natural gatedue to the arch of the walker pads, rigidly connected to said 112 finalfiberglass roll; and a 113 self adhering dressing, for securing theloose end of the final roll of fiberglass so that the fiberglass doesn'tunravel, rigidly connected to said 112 final fiberglass roll.
 16. A newmodlity and system for casting diabetic and neuropathic plantar footulcerations and treating defects that limit range of motion. forremoving the propulsive forces from the ulceration to expedite healingwhile promoting consitancy of application for the clinician, as well asreducing muscle tightness that occur for a variety of reasons andconditions, comprising: a 101 preferred wound dressing, for is toaddress the need of the specific wound; a new attribute 1 102stockinette, for an initial covering, protecting the leg and providing asurface for the attachment of proprietary felt medial and lateraloffloading and maleoli strips; a 103 self adhesive foam toe protector,for the protection of the toes during casting and removal of the cast,rigidly connected to said 102 stockinette; a 104 felt self adhesivelateral/medial offloading strips, for adding specific pressure to theleg which assists in proper distribution of weight and ensures easyremoval, rigidly connected to said 102 stockinette; a 105 felt selfadhesive lateral/medial maleoli strips, for assisting in properdistribution of weight and allows for easy removal, rigidly connected tosaid 102 stockinette; a 106 felt self adhesive tibial bridge, forprotection of the proximal tibial crest, rigidly connected to said 102stockinette; a 107 felt self adhesive mid-tibial protector, foradditional protection against rubbing of the prominent section of thetibial crest, rigidly connected to said 102 stockinette; a 108 elasticplaster roll, for first layer of rigid materal in an elastic compositproviding the intimate contact required to eleminate the risk offriction to the limb; a 109 first roll of fiberglass tape, for providinga hard rigid shell over the elastic plaster to secure the position ofthe limb to ensure proper body mechanics, rigidly connected to said 108elastic plaster roll; a 110 extra strength pre-fabricated posteriorsplint, for purpose of supporting the limb while re-distributing thepatient's weight over the surface of the foot, removing the directpressure from the wound, rigidly connected to said 109 first roll offiberglass tape; a 112 final fiberglass roll, for securing the extrastrength posterior splint as well as anchoring the proprietary rockerwalker in position; a 111 proprietary rubber rocker walker heel, forallowing the patient to ambulate normally while promoting a natural gatedue to the arch of the walker pads, rigidly connected to said 112 finalfiberglass roll; and a 113 self adhering dressing, for securing theloose end of the final roll of fiberglass so that the fiberglass doesn'tunravel, rigidly connected to said 112 final fiberglass roll.